Catheter Care Bundle and Low Catheter Infection Rates in a Home Parenteral Nutrition Population: A 4 Year Observational Study

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Abstract Background
Home Parenteral Nutrition (HPN) is often a life-saving therapy for patients. One of the most common complications for HPN is catheter-related blood stream infections (CRBSI). In the home setting there is no single de ned "care bundle" for the on-going maintenance of central venous catheters (CVC) for the prevention of CRBSI. We evaluated the impact of a standardized catheter care bundle in patients receiving HPN on the incidence of CRBSI.

Methods
Data collection included use of standardized tools and processes to capture patient demographics, catheter complications including CRBSI and some associated risk factors. Reported data was collected and analyzed annually and compared year-to-year from the years 2014-2017 from one national home infusion company. CRBSI reported as number of infections/1000 catheter days

Results
The CRBSI rate/1000 days was reported as 0.43, 0.31, 0.30 and 0. 23 (2014, 2015, 2016, 2017 respectively). The type of catheter, number of catheter lumens and type of nursing care provided had importance. In general, single lumen central venous catheters had numerically less CRBSI than double lumen central venous catheters; peripherally-inserted central venous catheters were the most common catheter used but also had the highest percentage of CRBSI.

Conclusion
The use of a catheter care bundle in an HPN population resulted in a 4-year reported outcomes of low and continuously declining CRBSI in a large, diverse United States-based HPN population.

Clinical Relevancy Statement
Catheter-related blood stream infections are a common complication of HPN therapy. There is no consensus on the clinical approach to prevention of CRBSI in the home setting. This study evaluated a catheter care bundle approach for the prevention of CRBSI in a large number of HPN patients.

Background
Home parenteral nutrition (HPN) is a treatment for patients with an inability to receive nutrients into and/or absorb nutrients from the small intestine. In general, patients receiving HPN are stable from a medical perspective and do not require hospitalization or care in a supervised medical facility.
Patients require a central venous catheter (CVC) for infusing PN (parenteral nutrition) solutions and sometimes other medical therapy. Because of the presence of a CVC, HPN patients are at risk for the development of catheter-related bloodstream infections (CRBSI). Of the reported complications of HPN therapy related to the CVC, CRBSI is the most common and is associated with signi cant morbidity and sometimes, mortality. (1) In addition to PN preparation and infusion, a patient and/or caregiver often must provide ongoing care for the CVC. Sometimes, a homecare nurse provides this care during weekly visits. Maintenance care includes activities such as catheter dressing, injection cap changes, and ushing of the CVC lumen(s).
The majority of CRBSIs stem from the ora found on the patient's skin. It is of utmost importance that the skin around the catheter insertion site be properly cleansed. (2) Overwhelming evidence has shown that using a 2% chlorhexidine antiseptic cleansing solution reduces the rate of CRBSI by up to 50%.(3) There are published reports on the importance of additional interventions to prevent CVC infection in the home setting including the use of disinfecting catheter injection caps, PICC stabilization devices, specialized dressings to prevent microbial growth, and dressing protection from water during bathing. (4,5,6) Patient and caregiver education are also important. Very few consensus professional society guidelines for care and maintenance of CVC in the HPN population exist. (7) Assessments have been made to understand the risk factors that a patient, caregiver or home setting may possess that would increase a patient's likelihood of developing CRBSI. (8,9,10) This can include, but is not limited to, shorter lengths of small bowel remaining after small bowel resection, patient history of alcohol, opioid or anti-anxiolytic drug dependence, lower socioeconomic status and a higher number of family dependents living in the home. Not all home settings are similar with regards to cleanliness and organization.
There also is variation in a patient or caregiver's ability to follow instructions.
Vast improvements have been made in the reduction of CRBSI in the hospital setting, attributed to standardization of the CVC insertion procedure. The groundbreaking Keystone Project demonstrated the effect of ve measures (a bundle) on the improvement of outcomes during insertion of central venous catheters. (11) Those components included hand washing prior to CVC placement, chlorhexidine skin preparation, full barrier precautions, use of the subclavian vein as the preferred access site and early removal of all unnecessary CVC. However, even in institutions where full compliance with the bundle exists, CRBSI are still occurring.(12) Of note, the Keystone Project central line bundle does not include any of the post-insertion aspects of CVC care and management which have been shown to prevent CVC infection The current study was initiated by a specialty pharmacy in the United States providing patient-speci c compounded HPN in addition to a variety of specialized medications to a diverse patient population with multiple physician providers. The decision to pursue this study was based on the ndings that HPN CRBSI rates were reported in the literature as persistently higher than other home infusion therapies, thus indicating a higher risk level for these patients. Four studies between the years of 2014-2019 indicate a range of CRBSI in the HPN population from 0.39-1.4/1000 catheter days. (13,14,15,16) It was hypothesized that a dedicated catheter care and maintenance bundle, using best available evidence, would reduce the overall number of CRBSI in an HPN population. A multi-modality catheter care bundle (CCB) including patient education and the use of novel catheter maintenance products was chosen to ensure mitigation of the risks associated with several known contributors to CRBSI, including skin contamination, catheter injection cap antisepsis, catheter pistoning and compromised or wet IV dressings.

Methods
A retrospective, non-randomized analysis was completed on an average of 7385 patients/year receiving HPN from a single national specialty pharmaceutical provider from January 1, 2014 to December 31, 2017. The primary outcome measure was development of CRBSIs which is expressed as the number of CRBSIs per 1,000 catheter days of HPN use by patients in that year. This data was compared year over year from 2014 through 2017. Data collected included demographic information, type of nursing provider, catheter type, number of catheter lumens and organisms responsible for the catheter infections when cultured.
As part of nutrition assessment, the Registered Dietitians completed a catheter history at the start of care, assessed compliance to catheter care as part of the ongoing nutrition assessment, and provided on-going education. The education provided reinforced catheter management. On-going patient interactions with a nurse in the home, clinical support specialist or pharmacist provided additional opportunities for catheter assessment and/or potential to capture a catheter event. All con rmed catheter events were then documented in the pharmacy provider's computer system.
Data was pulled from the pharmacy provider's computer system using a specialized query tool. No individualized chart review was performed. Two or more reported catheter infections occurring in the same patient in a 12-month period were reported to a Clinical Manager or designee to determine alternative care strategies and recommended follow-up education on an as-needed basis based on catheter complication rates, unused supplies and demonstrated non-compliance.
All HPN patients who were not ordered an institution or clinician-speci c catheter care protocol were provided with the CCB that consisted of 4 commercially available medical products in addition to the standard CVC catheter maintenance care which included regular catheter ushing, regular timing for injection cap change out, appropriate use of catheter securement devices, appropriate use of extension sets, routine catheter dressing changes, safe catheter clamping techniques and following of manufacturer guidelines: 1) 70% alcohol impregnated disinfection end cap 2) Foam disc impregnated with polyhexamethylene biguanide hydrochloride 3) Moisture barrier to help protect the intravenous dressing during showering.

4) Securement device for PICC
In conjunction with the CCB, an education program was initiated consisting of: 1. An internal education on the CCB to all home infusion nurses, pharmacists, dietitians and supporting nonclinical staff, 2. A letter outlining the CCB and its associated education program sent to the patients and their physicians and 3. Speci c patient education tools that addressed both catheter supply use and general guidelines for effective catheter care. This education was provided in addition to the direct education provided to patients and caregiver(s) on how to effectively use the CCB. Patients were also provided with a laminated mat that was to be used as the location to prepare their prescribed PN. This mat contained instructions for maintaining aseptic technique and provided reminders about CVC maintenance strategies for avoiding CVC complications, including CRBSI. The mat could also be easily cleaned prior to use. Catheter locking of solutions for prevention of CRBSI was not a common practice.
A catheter-related bloodstream infection was de ned as when a patient exhibits the following symptoms: fever over 100.4 not attributable to other health issues; catheter exit-site redness, drainage or cord; and also has either blood/catheter culture or gram stain con rmation of bacterial or fungal counts, or the prescriber determines that the catheter is the most likely source of infection, thus removing the catheter or treating the patient/catheter with anti-infectives. If the CRBSI symptoms develop less than 48 hours following hospital discharge, this would be considered a nosocomial infection, and not applicable to the home infusion setting. CRBSI symptoms developing 48 hours or more after central line insertion and care in the home infusion setting, this would be considered a nosocomial infection. (17) Patients admitted to the hospital for catheter infections were captured as part of the documentation process.
This was an observational study without patient randomization. Descriptive statistical reporting was performed on all collected data. Comparisons were made between categorical variables using the Chi Square test of independence and signi cance was set at p < 0.05.
All patient data was deidenti ed. CORAM/CVS internal clinical/ethics research committee reviewed the study, and determined that it meets the criteria of 45 CFR 46101(b). Our research involved the "collection of existing data, documents, records" and "information is recorded by the investigator in such a manner that the subjects cannot be identi ed directly or through identi ers linked to the subjects".

Level 3 -Patient Independent After Training and Demonstrated Competency
There were more female than male patients in this database. Numerically, females had a higher CRBSI/1000 days as compared to males although this was not found to be statistically signi cant in any reported year (Table 6). patients per year. It is likely that the bundled, standardized approach to catheter care contributed to this low incidence of CRBSI.
The incidence of CRBSI remains a topic of reporting from many clinicians and institutions. Table 7 provides a listing of reference articles for CRBSI infection in the HPN population and the reported CRBSI rates. (15,18,19,20,21,22,23,24,25,26,27,28,29) Only studies that included greater than 100 patients that were published since the year 2000 are listed in this table. These studies report a CRBSI rate between 0.35-3.20 per 1000 catheter days. These reports were also observational in nature. Some of the reports were based on surveys. No attempt was made to implement a speci c CRBSI practice in these publications other than the practice that was ordered by the responsible clinician or was the standard of practice for the pharmacy compounding the PN or the nursing agency providing care for the HPN patient. The de nition of CRBSI varied between the reported studies. There was no bundled approach to catheter care and maintenance. Many of these reports were single center reports and therefore do not represent a diverse patient population where multiple physicians are caring for patients at multiple unique sites. The majority of these studies reported out on only a small fraction of the patients included in this study. The type of nursing providing the CVC care and maintenance at home also impacted catheter outcome. The lowest CRBSI was noted with nursing employed or contracted by the specialty pharmacy home infusion provider or in patients who were "independent" and required no regular nursing visits (providing their own CVC maintenance and care). The highest CRBSI rate occurred in situations where the home infusion provider had no role in contracting with the assigned nursing agency, but rather that agency was assigned to the patient by the referral source or payer.
This study has its limitations. It is a retrospective, observational study. No attempt was made to equalize patient groups with regards to demographics or disease co-morbidities. No attempt was made to standardize the catheter care management interventions prior to the current CCB intervention bundle. Patient compliance with the CCB was not tracked. We did not collect data on a patient's gastrointestinal anatomy, socioeconomic status, level of education or degree of family support. However, the number of patients reported in this study is the largest report of any HPN database; these large patient numbers can often mitigate result errors noted in retrospective clinical study designs.

Conclusion
Home parenteral nutrition is a lifesaving therapy. Catheter-related bloodstream infection remains a common complication of the HPN population. In this study, we successfully achieved a reduction in CRBSI with the use of a bundled CVC care pathway designed to standardize safe maintenance practice after CVC insertion. To date, the current study is the largest patient number report of CRBSI occurrence in HPN patients.